Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylac… (NCT03838549) | Clinical Trial Compass
CompletedNot Applicable
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
France20 participantsStarted 2019-04-26
Plain-language summary
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.
Who can participate
Age range
20 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
* Ask an immediate breast reconstruction during the surgery
* World Heath Organization score \<3
* Glandular volume : french bra cup size A, B ou C
* Glandular ptosis \<=2 (Classification and Algorithm for Treatment of Breast Ptosis)
* Contraception for woman of childbearing age and no pregnancy
* Valid Social Security
* Wrote consent
Exclusion Criteria:
* History of breast cancer surgery
* Breast cancer not operated on the side concerned by the prophylactic mastectomy
* Patient having had irradiant treatment
* Breast hypertrophy
* Smoking \> 10 cigarette/day
* Body Mass Index \> 30
* Large breast volume requiring prostheses \> 500ml
* Chronic pulmonary obstructive gold 4
* ASA (Physical Status score of American Society of Anesthesiologists) \> 3
* Chronic shoulder pain on the side to operate, or both shoulders
* History of abarticular pathology of the shoulder on the operating side
* Patient involvment in another clinical research
* Protected patient or unable to give consent
* Pregnant or breastfeeding woman
* Vulnerable person (Article L1121-6 of the Public Health Code)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.